Tissue Therapy of Transsphincteric Anal Fistula
ConditionAnal Fistula
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern Denmark
About this trial
This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
able to communicate with Danish language
able to provide informed consent
having address in the region of southern Denmark during the study
Disqualifiers
Signs of suppuration/cavitation around the fistula
Simple or low anal fistula, which can be treated by simple surgical incision
Ano-vaginal and recto-vaginal fistula
The presence of more than one fistula tract, more than two external orifices or more than one internal orifice
Trial design
Design model
Parallel
Treatments tested in this trial
ADRC injection
DrugAllocated patients will receive injection of 5 ml suspension including 30 million autologous adipose-derived regenerative cells ADRC and injected at the same site of the lipoaspirate injection.
ADRC001 injection
DrugAllocated patients will receive injection of 5 ml suspension including 30 million allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection.
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Autologous ADRCExperimental treatment 1 intervention
Group B: allogenic ADRC001Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Healing rate (percentage)
Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation.
Time frame
at 6 and 12 months follow-upSecondary outcomes
1
QoL
functional outcome regarding quality of life, measured by Short Form SF-36 Rand questionnaire.
Time frame
at12 months follow-up.2
Fecal Incontinence
functional outcome regarding fecal incontinence, measured by Wexner Fecal Incontinence score.
Time frame
at12 months follow-up.3
Risk factors for recurrence of fistula.
Risk factors for recurrence of fistula including demography, prevoius surgery for fistula, disease duration and treatment arm.
Time frame
at12 months follow-up.4
Radiological healing.
Radiological healing, defined as no visible fistula or fluid collection more than 5 mm at MR imaging.
Time frame
at12 months follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov